Identity
- Trade Name
- RMO FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- PILOT DRILL FDA UDI
- Model / Reference
- G00231 FDA UDI
- Description
- PILOT DRILL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885797096340 FDA UDI
- FDA Product Code
- EKD FDA UDI
- GMDN Term
- Manual surgical rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual surgical rotary handpiece, reusable
RMO PILOT DRILL is a manually-powered, hand-held surgical device designed for precision drilling and cutting in dental procedures. This reusable device offers versatility with two main designs: U-shaped drill brace powered by the surgeon's hand or a side-mounted handle for cannulation.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rmo
Sources (1)
- FDA UDI 830f329a-d39f-4098-872e-704c3719362e 33 fields · synced Jul 17, 2026